Takeda’s antibody-drug conjugate gains second frontline indication following positive Phase 3 data

The European Commission (EC) has approved ADCETRIS (brentuximab vedotin) in combination with ECADD chemotherapy for adult patients with newly diagnosed Stage IIb (with risk factors), III, or IV Hodgkin lymphoma. The decision follows a positive CHMP opinion in April 2025 and is based on results from the Phase 3 HD21 trial.

The BrECADD regimen — which replaces components of the traditional eBEACOPP protocol with ADCETRIS — met both co-primary endpoints in the study. According to trial data, the combination demonstrated a significantly improved safety profile and non-inferior progression-free survival (PFS) when compared to the escalated BEACOPP regimen, which remains a standard of care in Europe.

The approval marks the second frontline indication in Hodgkin lymphoma for ADCETRIS, an antibody-drug conjugate targeting CD30, a biomarker associated with the disease. The therapy is now approved for seven distinct indications within the European Union.

The HD21 trial, led by the German Hodgkin Study Group, enrolled patients with advanced-stage Hodgkin lymphoma and evaluated outcomes using a PET-adapted design. Patients received two initial cycles of either escalated BEACOPP or BrECADD, followed by PET staging to guide further treatment. Safety was assessed using treatment-related morbidity (TRMB), a measure of clinically relevant acute toxicity. Efficacy was evaluated via PFS.

Speaking on the study outcomes, Professor Peter Borchmann, University Hospital of Cologne and HD21 trial chair, said: “With BrECADD, patients now have a treatment option that not only offers greater curative potential2* but also significantly reduces treatment-related morbidity compared to eBEACOPP.

“This new ADCETRIS-based combination therapy may offer a new standard of care for frontline treatment of adults with advanced stage Hodgkin lymphoma, contributing to improved long-term outcomes for patients.”

Takeda stated that the decision strengthens the role of ADCETRIS-based regimens in the treatment of CD30-positive lymphomas and supports more flexible treatment approaches based on patient profiles and disease stage.

The company’s submission included secondary endpoint data assessing tumour response, overall survival, infertility rates, and quality of life — metrics that could influence how the new regimen is adopted in clinical practice across Europe.